1. Field of the Invention
The present invention relates to a quickly soluble oral film dosage for effectively masking a unpleasant taste and, more particularly, to a quickly soluble oral film dosage comprising a stevioside based sweetener and a high potency sweetener in a ratio by weight (w/w) of 1:3 to 3:1, which may efficiently mask a bitter or nasty taste of a medicine and may be quickly dissolved in a mouth without water, thereby improving an aftertaste thereof thus enhancing dosage acceptability of a patient.
2. Description of the Related Art
A social distribution ratio of aged population has currently increased owing to an extended span of human life Old people generally show degenerated abilities including eyesight, hearing, memory, physical strength, etc. as well as pharmacokinetic variation, thus requiring suitable medical therapy. Especially, since they have difficulties in swallowing typical tablets or capsules, an alternative oral dosage formulation for aged persons may be required.
A quickly soluble film easily disintegrated or dissolved in a mouth can be taken without water, thus being useful for aged persons who have difficulties in swallowing tablets or capsules, handicapped children, patients in bed, and the modern people living a busy life, and so forth. For aged persons and children, a liquid type formulation may be prescribed instead of tablets and/or capsules. However, such liquid formulation has disadvantages such as deteriorated stability and incorrect dosage.
In particular, when a drug is absorbed in an oral mucosa, it may avoid passage of the drug through the liver. Therefore, the quickly soluble film dosage is preferably used for some medicines subjected to liver metabolism.
However, a film formulation easily dissolved in an oral cavity enables a drug to be absorbed in the oral mucosa, causing a bitter or nasty taste of the drug during absorption. Accordingly, ideas for blocking or masking such bad taste may be required.
In view of the foregoing circumstances, International Patent Publication No. WO 2001/70194 describes preparation of a quickly soluble oral film dosage as a taste masking agent by adsorbing active ingredients to an ion-exchange resin. However, the ion-exchange resin contained in a water-soluble polymer may cause scratches during forming and require a complicated processing.
International Patent Publication No. WO 2003/070227 describes use of a chemical compound such as sodium hydrocarbonate generating carbon dioxide so as to mask taste. However, sodium hydrocarbonate has limitations in masking a strong bitter taste.
International Patent Publication No. WO 2008/040534 describes a film formulation disintegrated and entered into the stomach without adhesion to the oral mucosa. However, the foregoing film formulation is prepared by a complicated method for considerably preventing absorption of the formulation to the oral mucosa and may not provide beneficial effects for protection of the stomach and bowels.
U.S. Patent Laid-Open No. US 2008/0044454 describes a preparation method of a uniform film comprising coating of an active material by a variety of coating techniques then introducing the coated active material into a film forming agent. Such coating process may complicate the preparation of film.